510(k) K093373
K093373 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "LARYNGEAL SURFACE ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 24, 2010. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Spes Medica Srl has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2010
- Date Received
- October 29, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type